CN1688357A - Improved airway device - Google Patents

Improved airway device Download PDF

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CN1688357A
CN1688357A CNA038241617A CN03824161A CN1688357A CN 1688357 A CN1688357 A CN 1688357A CN A038241617 A CNA038241617 A CN A038241617A CN 03824161 A CN03824161 A CN 03824161A CN 1688357 A CN1688357 A CN 1688357A
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portion
throat
member
balloon
ventilation
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CN100531818C (en
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默罕默德·阿斯拉姆·纳西尔
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默罕默德·阿斯拉姆·纳西尔
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/16Making multilayered or multicoloured articles
    • B29C45/1676Making multilayered or multicoloured articles using a soft material and a rigid material, e.g. making articles with a sealing part
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0409Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0415Special features for tracheal tubes not otherwise provided for with access means to the stomach
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0402Special features for tracheal tubes not otherwise provided for
    • A61M16/0431Special features for tracheal tubes not otherwise provided for with a cross-sectional shape other than circular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0436Special fillings therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0434Cuffs
    • A61M16/0445Special cuff forms, e.g. undulated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0486Multi-lumen tracheal tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04Tracheal tubes
    • A61M16/0488Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/049Mouthpieces
    • A61M16/0493Mouthpieces with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00Methods of manufacture, assembly or production
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29KINDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2995/00Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037Other properties
    • B29K2995/007Hardness
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE, IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor

Abstract

一种用于人类和动物通气装置,其包含一根具有一个远端部和一个近端部的通气导管,所述通气导管的远端部环绕着一个喉部囊适于在病人的喉部结构上形成一个符合解剖结构的密接,其特征在于所述装置进一步包含一个颊间隙固定件,所述颊间隙固定件位于喉部囊和导管近端部之间的通气管的上面或周围,并且所述颊间隙固定件适于与病人的舌前部相适配,其尺寸、形状、柔软度和轮廓适于防止通气装置在使用中的旋转或侧向移动。 The distal end portion of one kind of venting means humans and animals, comprising an airway tube having a distal portion and a proximal end portion of the ventilation catheter balloon surrounding a throat portion adapted to the patient's larynx forming a line with the adhesion of the anatomical structure, wherein said apparatus further comprises a fixing member buccal cavity, the buccal cavity, or around the fixing member located between the vent conduit and the proximal end of the balloon throat portion, and the said fixing member is adapted to buccal cavity and adapted to forward part of the patient, the size, shape, softness and contour adapted to prevent rotational or lateral movement of the aeration device in use.

Description

改进的通气装置 Improved breather

技术领域 FIELD

本发明涉及一种与解剖结构相适的、简易而又多功能的改进型通气装置。 The present invention relates to a simple but versatile improved ventilation apparatus suitable with the anatomy. 所述改进型通气装置特别用作,但不局限于,在外科手术中对能够自主呼吸的病人施行麻醉的装置。 The improved venting means in particular as, but not limited to, anesthesia apparatus in surgery on the patient to spontaneously breathing purposes. 本发明尤其涉及一种喉部通气装置。 The present invention particularly relates to a breather throat. 更具体地,本发明涉及一种可降低费用的、一次性的喉部通气装置,以及涉及制造此类通气装置的方法。 More particularly, the present invention relates to disposable throat venting means, and to methods of manufacturing such ventilation means capable of reducing cost.

背景技术 Background technique

提供一种清洁和非手持式的导气管,目前用在能够自主呼吸的接受麻醉的病人身上的装置的例子如下(其中所述病人为处于麻醉后恢复期间,处于重症监护隔离期间的某些病人,或者处于复苏期间):a)带有各种面具的Guedel通气装置;b)囊式口咽通气装置;c)喉部罩式通气装置(LMA)、增强型LMA、插管式LMA和用在ENT(耳鼻喉科)的Intavent改进型LMA;d)导气控制装置e)组合导管f)自固式鼻咽通气装置g)囊式或非囊式气管内导管、RAE气管内导管;h)声门上区口咽通气装置(Supraglottic oropharyngealairway);i)气管切开术和微气管;j)其他所有上述装置的使用均会明显和不同程度地引起并发病变,所述病变不仅包括令人难以接受的同步发生的生理性变化、而且包括暂时性和/或永久性的解剖结构上的损伤。 Providing a clean and non-handheld airway, currently used in the example means capable of receiving the anesthetized patient spontaneous breathing as follows (wherein the patient is under anesthesia After recovery period, some patients in intensive care during isolation during, or in recovery): Guedel venting means a) with a variety of masks; b) a capsule oropharyngeal means; c) the throat hood ventilation apparatus (LMA), reinforced LMA, LMA and cannulated with in ENT (ENT) of Intavent improved LMA; d) air guide control means e) a combination of a catheter f) self-retaining nasopharyngeal apparatus of formula g) the capsule or capsule endotracheal tube, the endotracheal tube RAE; H ) supraglottic oropharyngeal means (supraglottic oropharyngealairway); i) and micro tracheotomy tube; J) to all these other devices and are significantly different degrees of concurrent disease cause, including not only the cause for lesion unacceptable physiological changes occur synchronously, but also damage on the temporary and / or permanent anatomical structure. 由所述装置的使用而直接导致死亡的许多实例已经有报道。 By the use of the device as a direct result of many instances of death it has been reported.

设计方面最为成功的变化应该算是膨胀式喉部通气装置,所述膨胀式喉部通气装置的某些改进类型自1988年起已被用在输注麻醉气体方面。 Design changes should be regarded as the most successful expansion throat venting means, some modifications of the inflatable type breather apparatus throat since 1988 has been used in terms of an infusion of anesthetic gases.

有关此种通气装置的发展简史描述在AIJBrain所著的一篇论文中,该论文登载在《欧洲麻醉学期刊(the European Journal ofAesthesiology)》1991年增刊4的第5到17(含)页中。 A brief history about the development of such a ventilation device is described in a paper AIJBrain book, the paper published in the "European Journal of Anesthesiology (the European Journal ofAesthesiology)" 1991 Nian supplement the first 5-17 4 (including) page . 该论文的全部内容于此通过引用结合于本发明中,并构成发明的一部分。 The entire contents of this paper is incorporated by reference in the present invention, and constitute a part of the invention.

如果将呼吸树看作是终止于声门的导管,而目的为在所述导管和在低压下将气体供应到支气管树上的人工导管之间建立一个简易的连接,则在这两种导管之间形成一个直接的端对端的连接装置似乎符合逻辑。 If the respiratory tree is seen as a conduit terminating at the glottis, and the object is to establish a simple connection between the conduit and the gas is supplied at a low pressure to the bronchial tree artificial tube, catheter at both means forming a direct connection between seem logical end to end. 面具式确实可形成一种端对端的连接装置,但是其孔口不合适,尽管气体内导管与正确的孔口相接,但是其插入孔腔中太深,从而所述连接其实是靠孔内连接,而不是靠孔口边缘实现。 Indeed mask-forming apparatus is connected end to end, but the aperture is not appropriate, although the gas conduit in contact with the right aperture, but which is inserted into the bore is too deep, so that the connecting hole by the fact connection, rather than opening edge implementation. 气管内插管的不利方面可从这个事实看出:为了实现密封,将压力施加到上皮表面上,这将会影响其重要和独特的功能;另外,由于穿入到声带部位,由此引发的咳嗽将难以对付,会造成导气管上部结构的扭曲变形,同时插管前需要进行的喉镜检查、以及存在于气管中的气管内导管都将会刺激而使病人产生不想要的反射性反应。 The downside of the endotracheal tube can be seen from the fact that: In order to effect a seal, pressure is applied to the epithelial surface, which will affect its important and unique features; Further, since penetration to the site of the vocal cords, the consequent cough will be difficult to deal with, can distort the structure of the upper airway deformed, while the front laryngoscopy needed for the cannula, and the presence within the endotracheal tube in the trachea so that all will stimulate the patient to produce unwanted reflex response. 此类喉部罩具自1988年起就用于麻醉操作中,已有与此类喉部罩具的使用直接或间接有关的并发病变和/或病变的许多报道。 Such laryngeal mask has since 1988 used for anesthesia operation, many existing cover with throat with such use, directly or indirectly related to concurrent reported lesions and / or lesions. 并发症和/或病变是由于过度膨胀及囊内腔的压力压在与过度膨胀式囊接触的柔软的组织和软骨结构上而造成。 Complications and / or lesions due to excessive pressure expansion chamber and the capsule is pressed against the soft tissue and the cartilaginous structures in contact with the inflatable bladder caused by excessive.

已多次尝试对此类通气装置进行改进,但仍然存在一些严重的自身固有的缺点。 Several attempts have been improved to such a breather, but there are still some serious inherent drawbacks. 首先,需要将囊充胀到有效程度,由此麻醉气体(笑气)将能扩散到囊内,从而显著地增加了囊的内腔压力,进而易损的咽喉部位组织将承受相当大的压力。 First, it is necessary to inflate the balloon to the extent effective, whereby the anesthetic gas (nitrous oxide) can diffuse into the capsule, thereby significantly increasing the pressure of the lumen of the balloon, and further delicate throat tissues will be subjected to considerable pressure . 其次,在连接到麻醉设备的导管的近端部受力时,这些罩具易于侧向移动或绕着其纵轴旋转。 Secondly, when the catheter proximal end portion is connected to the force-receiving anesthesia equipment, which is easy to cover with lateral movement or rotation about its longitudinal axis. 应理解,在使用中如果将此类装置完全对称地放置,则通气导管将对准病人的鼻部。 It should be understood, if such devices are placed completely symmetrically in use then the airway tube will be aligned with the patient's nose. 然而,通气导管的任何旋转或侧向运动都有可能影响到通气装置在喉入口周围所形成的密封。 However, any rotational or sideways movement of the airway tube are likely to affect the seal around the laryngeal inlet vent means is formed.

专利文献中描述有若干种通气装置。 Described in the patent literature several types of venting means. 例如,美国专利(US5,976,072、Johns Hopkins大学)描述了一种光纤气管内插管装置。 For example, U.S. Patent No. (US5,976,072, Johns Hopkins University) describes an optical apparatus endotracheal intubation. 然而,这种装置基于膨胀式口咽囊,其具有如上所述的缺点。 However, such devices based on inflatable bladder oropharynx, which has disadvantages as described above.

美国专利(US5,865,176、O'Neil)和英国专利(GB2,319,182、VBM Medizintechnik Gmbh)描述了具有双膨胀式囊配置的通气装置,第一膨胀式囊用于形成病人咽部的密封、而第二膨胀式囊用于形成病人食道部位的密封。 U.S. Patent No. (US5,865,176, O'Neil) and British Patent (GB2,319,182, VBM Medizintechnik Gmbh) describes a ventilation apparatus having a dual configuration of the inflatable bladder, the first inflatable bladder for forming a seal in the patient's throat, and a second inflatable bladder for sealing a patient forming part of the esophagus. 这种配置加重了如上所述的组织损伤的问题。 This configuration exacerbate the problem of tissue damage as described above.

英国专利(GB2,373,88、Smiths Group plc)描述了一个对比性的配置,即一种膨胀式喉部罩具,带有一个设计成可防止罩具在插入过程中与会厌相互妨碍的裂口形的挡片。 British Patent (GB2,373,88, Smiths Group plc) describes a configuration of comparison, i.e., a inflatable enclosure having a throat, the epiglottis during insertion interfere with each other with a break in an enclosure designed to be prevented shaped flaps. 但是这仅是强调了此类膨胀式管状罩具具有向下插人的功能而已。 However, this is merely emphasizes the expandable tubular such an enclosure having a downwardly inserted human function only.

最后,在国际专利(WO00/61213、Brain)中,描述了一种一次性的、带有一个膨胀式囊的喉部罩式通气装置。 Finally, in the international patent (WO00 / 61213, Brain), there is described a disposable, throat hood ventilation apparatus having a inflatable bladder. 然而,此种装置不仅具有膨胀式囊装置所具有的全部缺点,而且由于由多个部件构成,增加了制造的成本和复杂程度。 However, such a device not only has all the disadvantages of an inflatable balloon device has, and because a plurality of members, increases the cost and complexity of manufacture.

所有这些专利为申请人所知的最为相关的现有技术。 All of these patents is known to the applicant prior art most relevant.

本发明的一个目的即为攻克或缓解这些问题的一部分或全部。 A is the object of the present invention to overcome or mitigate a portion or all of these problems.

发明内容 SUMMARY

本发明的第一个方面为提供一种通气装置。 A first aspect of the present invention is to provide a venting means.

相应地,依据第一实施例,提供了一种用于人类和动物的通气装置,所述通气装置包含一根具有一个远端部和一个近端部的通气导管,所述通气导管的远端部环绕着一个喉部囊,所述喉部囊适于在病人的喉入口部位形成一个符合解剖结构的密封,其特征在于所述装置进一步包含一个颊间隙固定件,所述颊间隙固定件位于喉部囊和导管近端部之间的通气导管的上面或周围,并且所述颊间隙固定件适于与病人的舌前部相适配,其尺寸、形状、柔软度和轮廓适于提供稳定性和能够防止通气导管在使用中的旋转或侧向移动。 Accordingly, according to the first embodiment, there is provided means for venting humans and animals, said venting means comprises a venting catheter having a distal portion and a proximal portion, the distal end of the ventilation catheter a throat portion surrounding the balloon, the balloon is adapted to the throat forming a seal against the anatomy of the laryngeal inlet site of a patient, wherein said device further comprises a buccal cavity fixing member, said fixing member located buccal cavity ventilation catheter balloon and the catheter between the proximal end of the throat portion or around, buccal cavity and the fixing member adapted to forward part is adapted to the patient, the size, shape, softness and profile adapted to provide a stable and ventilation catheter can be prevented from rotating or lateral movement in use. 该颊间隙固定件可由与囊相同或不同的材料制成,其助于所述装置在使用中的放置和定位。 The buccal cavity fixing member may be the same or different balloon materials, which facilitate placement and positioning of the device in use.

依据本发明的通气装置在下文中将被简称为NLA(Nasir喉部通气装置),该简称以发明人的名字命名。 Venting means according to the present invention will hereinafter be simply referred to as NLA (Nasir breather throat), which referred to the inventor named.

优选地,囊为非膨胀式,且预先制成一个形状,所述形状适于在病人喉部的结构上形成符合解剖结构的密接。 Preferably, the non-inflatable balloon, and a pre-formed shape that is adapted to conform to the anatomy of adhesion is formed on the structure of the patient's larynx. 杓会厌皱襞、杓状和小角软骨、杓状软骨间皱襞和梨状窝处使喉入口部位具有不规则的解剖结构。 Aryepiglottic fold, arytenoid cartilage and small angle between the arytenoid fold and piriform fossa laryngeal inlet portion having an irregular anatomical structures. 术语“喉入口部位”、“喉入口架构”和“喉入口结构”在以下说明书中可互换使用。 The term "throat entry site", "architecture laryngeal inlet" and "laryngeal inlet structure" are used interchangeably in the following description. 这些术语涉及病人喉入口部位及周围组织、皱襞和软骨,如附图1所示。 These terms refer to the patients laryngeal inlet portion and the surrounding tissue, folds and cartilage, as shown in Figure 1.

该装置的形状轮廓与咽喉部位的组织结构成互补性,因而能够与咽喉部位不规则的结构形成符合解剖结构的密接。 Structure and shape of the profile of the device into the throat of complementarity, it is possible with the throat irregular structure is formed in line with the adhesion anatomy. 同时,与使用膨胀式囊的情况相比,带有其设计符合解剖结构的杯/囊的装置也具有优点,所述膨胀式囊将产生一个相当大的内腔压力,完全大于22-26mm汞柱。 Meanwhile, compared with the case of using an inflatable bladder, designed to comply with the cup means anatomy / capsule also has the advantage that the inflatable bladder will generate a considerable pressure lumen entirely greater than 22-26mm Hg column. 在这个压力下,尽管所述囊具有柔软的结构表面,但仍将使与囊接触的人体结构产生扭曲变形、受压、移位、错位或破裂。 At this pressure, although the balloon surface having a flexible structure, but the structure of the body will make contact with the balloon twisted deformation, pressure, displacement, misplaced or broken. 囊反复充气膨胀以得到适宜的密封,但同时由圆形的、表面平滑的、绷紧的囊所形成的不当压力也将使周围组织结构扭曲变形,所述囊反复充气膨胀是导致咽喉部结构承受内腔压力的原因,而且所述内腔压力还会在囊使用中由于笑气(麻醉气体)被吸进囊的内腔而增大。 The balloon is repeatedly inflated to obtain a suitable sealing, undue pressure but a circular, smooth surface, formed by the balloon tight surrounding tissue structures will also distorted, the balloon is repeatedly inflated structure leading to throat Cause withstand the pressure lumen and the pressure lumen also because nitrous oxide (anesthetic gas) is drawn into the lumen of the balloon in the bladder is increased in use. 这将使囊压力迅速增大到超过100mm汞柱,使用一小时内,压力可升到超过200mm汞柱,这个压力完全超过毛细管血液供应咽喉部结构的细胞内压力。 This will allow the bladder pressure increases rapidly to more than 100mm of mercury, used within one hour, the pressure can rise to more than 200mm of mercury, this pressure completely over the throat portion of the intracellular structure of the capillary pressure of the blood supply.

优选地,喉部囊为预先成型、预先充气膨胀或预先填充上合适的流体。 Preferably, the throat sac preformed, pre-inflated or pre-filled with a suitable fluid.

优选地,适于在病人喉部结构上形成一个符合解剖结构特征的密接的喉部囊面,具有设计成能与病人喉部组织结构中的梨状窝处和杓会厌皱襞形成良好的密封的鼓出部。 Preferably, adapted to form a close contact surface of the balloon comply throat anatomical features of the patient in the larynx, the epiglottis designed to have a corrugated structure with a patient's larynx tissue pyriform fossa and dipper folds form a good seal bulging part. 同时优选地,候补囊的面还具有设计成能与舌下溪部(舌下沟valleculae)、会厌、杓会厌皱襞、梨状窝处形成良好的密封,并且能绕着甲状和环状软骨的前部形成良好密封的鼓出部。 While preferably, the balloon surface further having a candidate designed to sublingual Creek portion (sublingual groove valleculae), epiglottis, aryepiglottic folds, pyriform fossa form a good seal, and the front portion is rotatable about the thyroid and cricoid cartilage bulging portion forming a good seal. 环绕这些部位的密封性,可通过绕在喉部囊部分或全部周边上的一或多个羽毛状凸缘得以加强和提高。 Sealing surrounding these parts, by the balloon around the throat portion or the one or more feather-like flanges on the periphery of all strengthened and improved. 这个设计确保能够获得增大的密封压力,即完全能够超过30cm水柱。 This design ensures an increased sealing pressure can be obtained, i.e. more than 30cm of water can be fully.

在另一个优选实施例中,适于与病人喉入口部位形成紧贴密接的喉部囊的表面具有凹槽,所述凹槽设计成能确保供应喉部结构的重要的动脉、静脉和神经的通畅。 In another preferred embodiment, the surface is adapted to close the throat of the bladder is formed in close contact with the patient's laryngeal inlet portion having a recess designed to ensure that significant arterial supply of the larynx, veins and nerves unobstructed.

在一个特别优选的实施例中,喉部杯状套的远顶端的尺寸和形状适于在使用中使其保持在上食道括约肌的上面。 In a particularly preferred embodiment, the throat size and shape of the cup-shaped sleeve is adapted to keep the distal tip on the upper esophageal sphincter in use. 最为优选地,喉部杯状套的远顶端的形状为大体上凹形。 Most preferably, the throat jacket cup shape is generally concave distal tip.

在一个备选的实施例中,喉部杯状部件预先由一种适于吸收液体(比如水/粘液/血液或相似物质)的材料制成,从而引起所述喉部杯状套部件膨胀,进而与喉入口粘膜软骨(mucocartilagenous)的解剖相适配,所述材料例如用来制造TRMPAX(注册商标名)棉塞或压缩Gel Foam5(胶状泡沫)的CRM(棉和人造纤维混纺)。 In an alternative embodiment, the pre-cup-shaped member from a throat portion adapted to absorb liquid (such as water / mucous / blood or similar material) made of a material, thereby causing the sleeve member to expand throat cup, Further anatomy of the laryngeal inlet mucosal cartilage (mucocartilagenous) is adapted to, for example, the material used to fabricate TRMPAX (registered trade name) or the compressed tampon Gel Foam5 (bubble gum) in the CRM (cotton rayon and blends).

优选地,颊间隙固定件具有一个第一面、即腹面,其大体上与喉部囊的开口面同处一个平面,并且所述颊间隙固定件的第一面的形状为大体凹形。 Preferably the buccal cavity fixing member having a first surface, i.e., the ventral surface of the opening which is substantially the same throat bladder at a plane, and the surface shape of the first fixing member buccal cavity is generally concave. 这有助于操作人员将装置插入病人以及使颊间隙固定件与病人的舌部接触。 This helps the operator of the device into the patient and causing buccal cavity in contact with the fixing tongue of the patient.

优选地,颊间隙固定件从喉部囊的近端部向着通气导管的近端部延伸,从而囊和颊间隙固定件成为一体构造。 Preferably the buccal cavity in the proximal portion fixing member extending from the proximal end of the ventilation catheter balloon portion throat, buccal cavity and the balloon such that the fixed member integrally structure. 这就提供了一种平滑和精致的装置,具有吸引人和实用的设计样式。 This provides a smooth and sophisticated means have an attractive and practical design style.

优选地,颊间隙固定件的宽度W不一致,在喉部囊和通气导管的近端部之中具有一个宽度点,并且更为优选地,所述颊间隙固定件的宽度点更加靠近喉部囊、而不是更加靠近通气导管的近端部。 Preferably, the width W of the buccal cavity inconsistent fixing member, having a width at the proximal portion of the throat point and the balloon catheter into the ventilation, and more preferably, the width of the buccal clearance fixing point closer to the throat of the balloon member , rather than the more proximal portion of the catheter near the vent. 这个设置使得所述固定件在使用中可以最宽的区域放在病人的舌底部上并与其相接触。 This area of ​​the fixing member is provided such that, in use, can be placed in the widest and in contact with the patient's tongue on the bottom.

优选地,颊间隙固定件的宽度W在其最宽点处与处在同一点处的颊间隙固定件的高度H的比率为2.7±10%。 Preferably, the width W, buccal cavity fixing member at its widest point to the height H of the buccal cavity at the same point of the fixture ratio of 2.7 ± 10%.

有利地,颊间隙固定件与病人舌部接触的面可为粗糙面,以在使用中增加与舌部的摩擦。 Advantageously, the fixing member surface buccal cavity in contact with the patient's tongue may be roughened to increase friction with the tongue in use.

在另一个备选的实施例中,颊间隙固定件的尺寸可调整,例如其中的颊间隙固定件被制成一个部件,所述部件的至少一部分以可滑动的形式装在通气导管上。 In another alternative embodiment, the size of the adjustable fastener buccal cavity, the buccal cavity, for example, wherein the fixed member is a member formed, at least a portion of the member slidably mounted on the airway tube form.

在一个特别优选的实施例中,将颊间隙固定件制成通气导管的一个组成部分,进一步优选地,将颊间隙固定件、通气导管和喉部囊制成一体。 In a particularly preferred embodiment the buccal cavity fixing member made of a part of the ventilation catheter, more preferably, the fixing member buccal cavity, throat airway tube and balloon are integrally formed.

各个零件、组成部分或部件的肖氏硬度是本发明的一个重要特征。 Shore hardness of the various parts, elements or components is an important feature of the present invention. 例如,优选地,喉部囊由肖氏A级硬度等于或小于40的材料制成,并且更加优选为0到20、最为优选为4到12。 For example, preferably, the bladder is equal to the throat a Shore A hardness of less than 40, or made of a material, and more preferably 0-20, most preferably 4-12.

优选地,喉部囊和颊间隙固定件的前部分、即腹面部分由肖氏硬度大体相同的材料制成。 Preferably, the front portion, the throat and the balloon fixing member buccal cavity, i.e., the ventral portion is made of a material substantially the same Shore hardness. 这使得构造简易化,并且确保了与病人的柔软组织接触的所述装置的所有部位均比较柔软。 This enables simplified construction and ensures that all parts of the soft tissue of the apparatus in contact with the patient are relatively soft.

在另一个优选的实施例中,装置的后部件或叫背面部件和装置的前部件或叫腹面部件由肖氏硬度不同的材料制成。 In another preferred embodiment, the components of the device called the front or the back surface member and the member or device is called the ventral part is made of a Shore hardness of different materials. 这确保了背面部件可由比腹面部件更坚实的材料制成。 This ensures that the back part may be made firmer material than the ventral part.

优选地,后部件或背面部件由肖氏A级硬度小于60的材料制成,更加优选为25到45之间,最为优选为30到40之间。 Preferably made of a material, member or the back surface member after a Shore A hardness of less than 60, more preferably between 25-45, most preferably between 30 to 40.

同时应该理解,喉部囊可为膨胀式。 It should also be appreciated that the throat may be a balloon expandable type. 尽管这并不理想,但相对于现有技术的膨胀式罩具,其仍然代表了明显的进步。 Although this is not ideal, but relative to the expansion enclosure with the prior art, it still represents a significant step forward.

优选地,所述装置可进一步包含一个胃管通道,其从囊的突出顶端延伸到上述装置的近端部。 Preferably, the device may further include a tube passage extending from the top of the protruding portion of the bladder to the proximal end of the apparatus.

依据本发明的第二个方面,提供了一种制造通气装置的方法,包含以下步骤:(a)制出所述装置的第一部件和第二部件的模制件; According to a second aspect of the present invention, there is provided a method of manufacturing a ventilation device, comprising the steps of: (a) manufactured by the molding of the first and second parts of the apparatus;

(b)通过连接件将第一部件和第二部件接在一起。 (B) through the connecting member and the second member of the first member together.

相对于现有技术的制造方法,其通常设计成多个部件,依据本发明的制造方法显得相当简单。 With respect to the prior art manufacturing method, which is generally designed as a plurality of members, the manufacturing method according to the present invention it seems quite simple.

优选地,第一部件为装置的前部件、即腹面部件,其包含有喉部囊的表面,而第二部件为后部件、即背面部件,其中第一和第二部件由肖氏硬度相同或不同的材料制成。 Preferably, the first member is a front member of the device, i.e. ventral member, which throat portion comprising the balloon surface and the second member is a rear part, i.e. the back member, wherein the first and second member by the same or a Shore hardness It is made of different materials.

依据本发明的第三个方面,提供了一种制造包含有一根通气导管、一个喉部囊和一个颊间隙固定件的通气装置的方法,所述方法将所述装置制成连在一起的塑料模制件,优选地其中所述装置以注塑法制成。 According to a third aspect of the present invention, there is provided a method of manufacturing a catheter comprising a vent, a vent device and a buccal cavity throat balloon fixture, the method the device is made of plastic together molding, preferably wherein said means to injection molding method.

附图说明 BRIEF DESCRIPTION

现参考附图,并且仅通过实例对本发明进行描述,其中所述附图如下:附图1A到C显示了喉部软骨和韧带的不同视图。 Referring now to the drawings, and will be described only by way of example of the present invention, wherein the following figures: Fig. 1A to C show different views of the throat cartilage and ligaments. 这个图示摘自Tortora GJ、Grabowski G和Reynolds S.的《解剖学和生理学》(John Wiley、2003年第10辑第781页)。 This illustration is taken from Tortora GJ, Grabowski G and Reynolds S. of "Anatomy and Physiology" (John Wiley, 2003, pp. 781, Series 10). 于此通过参考引用了该文的内容和图解;附图2和3显示了本发明的两个实施例的平面图;附图4到7为另外两个实施例的部分分解图,每一通气装置显示成两个部件,夹在其间的是一根通气导管;附图8显示了第二通道或涵道的备选特征,所述第二通道或涵道始于NLA近端部的侧位,向着远端部弯曲延伸,从而其远开口位于NLA导管的后背部,并穿入到罩具中,进而可插入胃管;附图9显示了一个纵向裂缝,其大体上沿着罩具的长度方向延伸,以能容纳气管内导管,用在意料中或意料外存在插管困难的情况,此时有或没有探条、Cook's导气管或光纤窥镜均可; Herein by reference the contents of the text and illustrations; Figures 2 and 3 show a plan view of two embodiments of the present invention; Figure 4-7 is a partially exploded view of two further embodiments, each of the venting means shown as two members, it is sandwiched therebetween a vent conduit; Figure 8 shows a second alternative features or ducted channel, the second bypass passage or NLA began lateral proximal portion, extends toward the distal end portion bent so that its distal opening of the catheter back rear NLA, and penetrates into an enclosure, the tube further may be inserted; Figure 9 shows a longitudinal crack, which generally along the length of an enclosure extending direction, to accommodate the endotracheal tube, the expected use in the presence or difficult outer cannula unexpected, this time with or without bougie, Cook's airway or fiber-optic endoscope can;

附图10.1到10.6显示了本发明另一个实施例的多个平面图、侧视图和截面图;附图11、12和13显示了依据本发明的另一个实施例的两个前视图和一个侧面图或侧视图,其中颊间隙固定件的尺寸可调整;附图14概略地显示了接合在喉入口部位上的、依据本发明的通气装置;附图15(已删除);附图16为通气装置的一些透视图、横截面图和部分分解图,显示了通气导管其自身可露出在所述装置的主体上;附图17A到F显示了本发明另一个优选实施例的前视、后视、侧视和端视立面图;附图18A、B和C显示了特别优选实施例的前视和侧视立面图,其具有环绕着喉部囊的一部分边缘延伸的、薄且柔韧的凸缘;附图19、20和21显示了依据本发明的、正在用在病人身上的装置的示意性横界面图和等距视图;附图22显示了沿着如附图21所示的线YY的切面。 Figures 10.1 to 10.6 show various plan another embodiment of the present invention embodiment, a side view and a sectional view; figures 11, 12 and 13 show two front views according to another embodiment of the present invention and a side view size or side view of the adjustable fastener buccal cavity; Figure 14 diagrammatically shows, in accordance with the present invention, venting means is joined to the laryngeal inlet site; Figure 15 (deleted); Figure 16 is a breather Some perspective, partially exploded view and a cross-sectional view showing the ventilation catheter itself may be exposed on the body of the device; Figure 17A to F show front view of a preferred embodiment of the present invention, further, a rear view, side and elevational end view; Figure 18A, B and C show front and side elevation particularly preferred embodiment, the edge portion having a throat portion surrounding bladder extending, thin and flexible projections edge; figures 19, 20 and 21 show schematic cross-interface based on FIGS being used on a patient and apparatus of the present invention is an isometric view; Figure 22 shows along line YY as shown in Figure 21 facets.

具体实施方式 Detailed ways

以下仅通过实例对本发明的具体实施方式进行描述。 Only the following description of specific embodiments of the invention by way of example. 尽管这些实例不是本发明仅有的实施方式,但其代表了实施本发明的最佳方式,是申请人目前所掌握的实施方式。 Although only these examples are not embodiments of the present invention, but it represents the best mode embodiment of the present invention, the applicant is currently available embodiments.

附图2显示了依据本发明第一实施例的罩具装置(maskdevice)的远端部(distal end),通常标为10。 Figure 2 shows the distal end portion (distal end) having means (maskdevice) cover according to the first embodiment of the present invention, generally designated 10. 所述罩具装置包含一根通气导管11,所述通气导管11终止于位于所述罩具装置近端部12(未显示)上的15mm连接件或其他适于与普通类型的吸气式麻醉系统(an anaesthetic breathing system)连接的连接件处。 The apparatus comprises a housing having a vent conduit 11, the ventilation duct 11 terminates at the proximal end of the shroud 12 having means (not shown) on a 15mm or other connector suitable for ordinary type suction anesthesia the system (an anaesthetic breathing system) member at the connection. 喉部囊或杯14形成于通气导管的远端部13周围,其形状和轮廓适于与病人的喉入口部位相吻合。 Throat bladder or cup 14 is formed around the distal end portion of the ventilation catheter 13, which is adapted to the shape and contours of the patient's laryngeal inlet portion coincide. 在这个前提下,术语“囊”和“杯”具有相同的含义。 In this context, the term "balloon" and "cup" has the same meaning. 其均指所述装置的部件,位于通气导管的远端部,适于覆盖住病人的喉入口、并形成密封。 Which refer to components of the device, located at the distal end portion of the ventilation catheter, adapted to cover the patient's laryngeal inlet, and forms a seal. 在本说明书中,术语“近端”指的是最接近吸气式麻醉系统连接件的所述装置的端部、或所述装置的一部分。 In the present specification, the term "proximal" refers to the end of the device closest to the intake connecting piece anesthesia system, or a portion of the device. 术语“远端”指的是离所述吸气式麻醉系统最远的所述装置的端部、或所述装置的一部分。 The term "distal" refers to a portion of the device furthest from the aspirating end anesthesia system, or of the device.

一般地,专家对喉部囊相当熟悉,在附图1A、B和C中,比较详细地显示了人类喉入口部位的解剖结构。 Generally, experts familiar throat bladder, in figures 1A, B and C, shows in more detail the inlet portion of the anatomy of the human throat. 附图2所示的特别的囊在其面上具有明显的凸出部或鼓出部15、16,其被设计成可在梨状窝处和杓会厌皱襞(aryepiglottic folds)上形成良好的密封。 In particular capsule shown in the drawings with significant projections or bulging portion 15, 16 on its surface, which is designed to form a good seal in the piriform fossa and aryepiglottic folds (aryepiglottic folds) on . 应能看出标为15和16的囊的向外凸出部被置于前外侧(ANTERO-LATERALLY),适于放入所述的梨状窝处和杓会厌皱襞,从而具有解剖结构上的密封作用。 Should be able to see marked bladder 15 and outwardly projecting portion 16 is disposed at the front outside (ANTERO-LATERALLY), adapted into the piriform fossa and aryepiglottic folds, so as to have the anatomical structure sealing effect. 因而从侧视图看,囊的面并不是一个平齐的平面,而是含有从囊的面所处的主平面上鼓出的部分。 Thus from the side view, the balloon is not a plane surface flush, but contains the main plane of which bulge from the surface of the balloon portion. 另外,也可以包含有位于囊的面所处的主平面的下方的部分。 Further, there may also comprise part of the surface which is located below the main plane of the bladder. 开口17周围的囊面的表面形状和总尺寸、以及外形和轮廓均为本发明重要的特征。 Around the opening 17 of surface shape and overall size of the balloon surface, and the shape and profile are important features of the present invention. 在附图3、5、10、11、12、17和18中显示了囊的面的其他形状,并在以下更详细地对其进行描述。 Other surface shapes shown in the drawings bladder 3,5,10,11,12,17 and 18, and described below in more detail thereof.

该装置可由经过材料专家选择的、任何适合的塑料材料制成。 The device may be selected through the materials specialist, made of any suitable plastic material. 不含乳胶的(Latex-free)医用级硅胶是一种优选的材料。 Free latex (Latex-free) of medical grade silicone is a preferred material. 囊应该质地柔软以避免对周围组织造成不当的损伤。 Bag should be soft to avoid undue damage to surrounding tissue. 制造此类装置的其他合适的材料包括,但不局限于,聚氯乙稀(PVC)、热塑性弹性体(比如苯乙烯嵌段共聚物,如苯乙烯-丁二烯-苯乙烯(SBS)、苯乙烯-乙烯-丁烯-苯乙烯(SEBS))、以及热塑性聚烯烃类混和物(TPO)、热塑性聚氨酯(TPU)、共聚酯(COPE)、聚酯和聚酰胺整体共聚物(PEBAX),及其泡沫形式(如适宜)。 Other suitable materials for producing such devices include, but are not limited to, polyvinyl chloride (PVC), thermoplastic elastomers (such as styrene block copolymers such as styrene - butadiene - styrene (SBS), styrene - ethylene - butylene - styrene (SEBS)), and thermoplastic polyolefin blends (TPO), thermoplastic polyurethane (TPU), copolyester (COPE), a copolymer of polyester and polyamide overall (PEBAX,) , and foam (if appropriate).

另一个涉及合适材料选择的重要因素是透明度。 Another important factor involved in selecting a suitable material is transparency. 理想地,制造所用的一或多种材料应大体上清澈或透明。 Desirably, one or more of the materials used should be substantially clear or transparent. 这就确保麻醉师或操作人员能看到导气管的内腔,以便检查堵塞或其他问题。 This ensures that the anesthetist or operator to see the airway lumen in order to check blockage or other problems. 材料专家熟悉此种透明材料。 Materials experts familiar with such transparent material.

在一个优选实施例中,囊为非膨胀式,并由任何合适的柔软塑料材料制成。 In a preferred embodiment, the balloon is non-inflatable and made of any suitable flexible plastic material. 对于优选的柔软度(硬度)范围,以肖氏A级硬度为基准,接触喉入口的囊的面的最适宜的硬度应小于40。 For the preferred softness (hardness) range, Shore A hardness as a reference, optimum contact with the laryngeal inlet of the bladder surface hardness of less than 40. 而对于该优选范围,依据相同的标准,优选的硬度值为0到20之间,其中特别优选的范围为4到12。 For this preferred range, according to the same standards, hardness is preferably between 0 and 20, particularly preferred in the range of 4-12. 可通过在囊自身的主体之中制出空洞或孔道,进一步改进囊的柔软度(如附图4和5所示)。 It may be prepared by the voids or pores within the body of the balloon itself, to further improve softness of the balloon (as shown in Figures 4 and 5).

在另一个优选实施例中,囊可预先填充上流体,比如空气、或其他无毒气体、或无毒液体。 In another preferred embodiment, the balloon may be pre-filled with a fluid, such as air, or other non-toxic gas, or a non-toxic liquid. 在这个前提下,术语“流体”具有广泛的涵义,其包含任何合适的气体、液体、蒸汽及其组合物,并由解剖学麻醉学领域的专家会同材料专家进行确定和设计。 In this context, the term "fluid" has a broad meaning comprising any suitable gas, liquid, vapor and combinations thereof, by anatomical specialist field of anesthesiology determined in conjunction with the material and design experts. 囊将由这么一种材料制成,所述材料使得笑气(麻醉气体)不能以显著的数量从该材料中扩散,从而外加的(extra)的腔压得以保持恒定。 Bladder formed by such a material so that said material nitrous oxide (anesthetic gas) to diffuse from the material is not in a significant amount, so that the plus (Extra) to maintain a constant weight of cavities. 因此,其符合了这个要求,即对于其内填充的液体,以及麻醉气体,囊应该大体上具有防渗透性。 Thus, compliance with this requirement, i.e. for a liquid filled therein, and an anesthetic gas, the balloon should have a substantially preventing permeability.

另外,囊可由柔软的泡沫材料制成,或可填入泡沫材料。 Further, the bladder may be made of a soft foam material, a foam material or may be filled. 这两种情况均可在囊的面的周围得到一个柔软、可变形而又有固定形状的表面,以能接合在喉入口部位的解剖结构上。 In both cases, the peripheral surface of the balloon can be obtained a soft, deformable and have a fixed shape of the surface, to be able to engage on the anatomy of the laryngeal inlet portion. 此种填充泡沫的装置将使该部位组织结构的潜在性损伤减到最小,同时仍然具有大体上良好的密封性。 Such a foam filled device will potentially damage the portion of the tissue structure to minimize, while still having a generally good sealing.

紧邻喉部囊/杯,且位于靠近囊的通气导管一端的是一个颊间隙固定件(stabiliser)20。 Balloon proximate the throat / cup, and located adjacent an end of the ventilation catheter balloon is a buccal cavity fixing member (stabiliser) 20. 在这个实例中,该固定件所采用的样式为:在通气导管两侧对称伸出的突出体。 In this example, the fixing member style is used: symmetrical protrusion extending on both sides of the ventilation catheter. 这个固定件适于放置在舌的前区或前部,并且其形状与病人该部位的解剖结构相吻合。 The fixing member adapted to be placed in the front zone or front of the tongue, and the shape of the portion of the patient's anatomy coincide.

固定件的形状、尺寸以及所处的位置可具有多种变化。 Position of the shape of the fixing member, and the size of which may have a variety of variations. 附图2所述的固定件的面为相对于囊的面所处的平面的曲面,附图2中所看到的固定件的面为稍微凹入的曲面,而其背面则稍微凸出。 The surface of the fixing member 2 of the drawings is curved with respect to the plane in which the surface of the balloon, as seen in Figure 2 of the surface fastener surface is slightly concave, while the rear surface is slightly convex. 固定件的面可以是粗糙、带划痕或带齿,以增加与舌部之间的摩擦,从而在使用中可将其固定,避免或减少使用中的前后移动。 The fixing member may be rough surfaces, scratches or toothed belt, to increase the friction between the tongue portion, whereby it can be secured, in use, to avoid or reduce the use of moving back and forth.

在这个实例中,固定件与囊制成一体,从而其中一个可平滑地接入另一个。 In this example, the bladder is formed integrally with the fixing member, so that one can access another smoothly. 然而,这不是必须的,固定件可作为通气导管上一个独立的部件。 However, this is not essential, as the fixing member can be a separate ventilation catheter member. 该固定件的一个实质特征是其横截面的宽度大于通气导管自身的直径。 An essential feature of the fixing member is a cross-sectional width greater than the diameter of the ventilation catheter itself. 也就是说,其在通气导管的两侧各延伸出一个部分,并处于与喉部囊相同的主平面上。 That is, each of the ventilation catheter extending on both sides of a portion of the throat and the balloon is on the same main plane. 该颊间隙固定件优选的尺寸将在以下论述。 The fixing member is preferably buccal cavity dimensions will be discussed below.

不同设计的颊间隙固定件的另一个实例显示在附图11、12和13中。 Another example of a different design of buccal cavity fixing member shown in figures 11, 12 and 13. 在这个实例中,固定件50可调整,在两侧具有两个侧钩51、52,靠近通气导管的近端部,其可上下滑动以增大或减小凸缘(flanges)的尺寸,以起到适宜的稳定作用,并且易于NLA的插入和拔出。 In this example, the fixing member 50 is adjustable on both sides with two side hooks 51, 52 near the proximal end portion of the ventilation catheter, which is slidable up and down to increase or decrease the size of flanges (flanges) to suitable stabilization functions, and easy insertion and removal of the NLA. 所述钩与棘齿条(ratchet strips)53、54咬合,所述棘齿条53、54形成于通气管相对的两侧。 And the hook ratchet (ratchet strips) 53,54 engagement, the ratchet bar 53, 54 formed on opposite sides of the vent. 所述固定件由极易变形的、柔韧的材料制成,从而在将钩从如附图11所示的位置推到一个更加靠近位于导管远端部上的囊的位置时(如附图12所示),固定件在通气导管两侧的延伸随着钩越移向囊,则固定件越宽。 (Such as the FIG. 12 position fixing member made of highly deformable, made of pliable material, so that the hook from the position as shown in the figures 11 to push on a balloon positioned closer to the distal end portion of the catheter shown), extending on either side of the fixed member of the ventilation catheter as the hook moves toward the balloon, the wider the fixing member. 因而该固定件可从连接件下方的通气导管的近端部延伸到喉部囊的近端部。 Thus the fixing member may extend from the proximal end portion of the ventilation catheter to the proximal end member connected to the bottom of the throat portion of the balloon. 所述固定件的形状大体上对称,并可往下滑动,以在颊间隙的横向上得到延展的形状。 A shape substantially symmetrical to the fixing member, and slide down, in order to obtain a shape extended in the transverse direction of the buccal cavity. 附图13显示了该实施例的斜侧视图。 Figure 13 shows an oblique side view of the embodiment.

这仅是可用于制造固定件的许多方法中的一种。 This is only one of many methods available for manufacturing a fixing member in. 固定件可由任何(优选为柔软的)环绕着通气管壁的、可靠在舌前部的延展面形成。 By any fixing member (preferably flexible) surrounding the ventilation pipe wall surface reliably formed in the forward part of the extension. 任何具有合适形状的、侧向延伸的、其主体主要沿着通气导管的纵轴延展的凸缘均可起到这个作用。 Having a longitudinal axis extending flange of any suitable shape, extending laterally along its main ventilation catheter body can play this role. 所述凸缘不一定是实心,因而管状、网状或其他有孔结构体都是可行的。 The flange need not be solid, so a tubular, mesh or other porous structures are feasible. 优选地,在沿着如附图11所示的方向,即沿着囊的面的法线方向看时,所述固定件具有凹面或凹部,所述凹面或凹部与病人舌前部大体上相适配。 Preferably, at the time, i.e., viewed along the normal direction of the surface of the balloon in the direction 11 as shown in the figures, the fixing member has a concave or recess portion, the concave portion or recess portion are substantially the patient Tongue adaptation.

也可以通过在囊上方适宜的部位,拓宽通气管的轮廓而形成一个“凸缘”。 May also be suitable by the upper bag portion, the vent widening contour form a "collar." 也就是说,颊间隙固定件可以是通气导管的一个组成部分,而不是一个形成于或环绕在通气管上的独立部件。 That is, the fixing member buccal cavity may be an integral part of the airway tube, rather than in a separate component formed on or around the vent tube. 因而,通气导管主轮廓上的一个合适的增大部分,不管其由导管自身形成或通过在通气导管的周围加上额外的材料制成,均可作为一个固定件。 Accordingly, a suitable portion of the airway tube increased Main Profile, whether formed by the catheter itself or by additional material made around the ventilation catheter plus, can be used as a fixing member.

可在附图16、17A和B中详细地看到颊间隙固定件的一般轮廓以及其平滑地与囊结合的方式,并且将在以下更加详细地描述。 16,17A and B can be seen in the drawings in general outline buccal cavity and the manner in which the fixing member is smoothly bonded to the balloon detail, and will be described in more detail below. 然而应能理解,如果通气导管的内径或内部轮廓相应地随着颊间隙固定件的宽度变化而增减,则可降低重量和减少塑料材料的使用。 However, it should be appreciated that if the inner diameter of the ventilation catheter or inner contour corresponding with the width of the buccal cavity fixture change increases or decreases, the weight can be reduced and reduce the use of plastic materials. 于此采用了术语“内部轮廓”,原因是在通气导管扩宽时,其变成非圆形,呈现出一个大体上椭圆的形状。 Employed herein the term "internal profile" because when the venting catheter widened, it becomes non-circular, showing a substantially elliptical shape. 由此应该理解在这个实施例中,在颊间隙固定件的宽度增加到其最宽点的过程中,通气导管的横截面积先增大,而后再减小。 Whereby it should be understood that this embodiment, which increases the width of the widest point of the buccal cavity during the fixing member, the first cross-sectional area of ​​the ventilation catheter increases, and then decreases. 通过最大化通气导管的宽度,可以加大装置内的层流。 By maximizing the width of the ventilation duct, a laminar flow within the device can be increased.

附图11所示的通气装置的另一个特征为:在囊的面上具有两组鼓出部或凸出部56、57和58、59。 Another feature of the ventilation device 11 shown in the drawings is: with two bulging or projection portion 56, 57 and 58, 59 on the balloon surface. 这两组中的较大一组56、57适于环绕杓会厌皱襞和放于梨状窝处中。 Larger set of 56, 57 adapted to encircle the two sets aryepiglottic folds and in the pyriform placed in the fossa. 两组中的较小的一组58、59则适于环绕甲状软骨和环状软骨。 Two groups 58 and 59 is set smaller adapted to surround the thyroid cartilage and cricoid cartilage. 另外,囊的顶端55为柔软的锥形凸出部,优选地,所述顶端55为非膨胀式。 Further, a soft capsule 55 to the top portion of the tapered projections, preferably, the tip 55 is non-inflatable.

另一个实例显示在附图3中。 Another example is shown in Figure 3. 附图3显示了通气装置30,具有一个囊34和一个颊间隙固定件40。 Figure 3 shows an aeration device 30 having a balloon 34 and a fixing member 40 buccal cavity. 在该实例中,囊的两侧具有两组凸出部或鼓出部35、36和38、39。 In this example, the two sides of the bladder has a projection or bulging portion 35, 36 and 38, 39. 上面的一组(38、39)包含一侧一个的两个鼓出部,设计成可放置在杓会厌皱襞和梨状窝处。 A set of two bulging portions (38, 39) comprising a top side, designed to be placed in the aryepiglottic folds and pyriform fossa. 下面的一组(35、36)设计成可放置甲状软骨和环状软骨。 A group of the following (35, 36) designed to be placed in the thyroid cartilage and the cricoid cartilage. 这些凸出部的相对尺寸由适宜专家确定。 The relative size of the projections is determined by the appropriate specialist. 设计成放置在杓会厌皱襞和梨状窝处中的凸出部38和39,一般而言稍微大于下面的两个凸出部。 Designed to be placed in the aryepiglottic folds and in the pyriform fossa projections 38 and 39, following in general slightly larger than two projections. 囊的远/较低的端部柔软但牢固,并且优选地,不需要预先膨胀或预先填充,以易于装置的插入以及适于放在喉部和食道之间。 Distal / lower end portion of the flexible bag but strong, and preferably, does not require pre-inflated or pre-filled, and to facilitate the insertion device is adapted to be placed between the larynx and esophagus. 在附图4到7中显示了其进一步的变化,表明了在这个总的设计概念下其所具有的机动适应性。 Shows a further variation in the figures 4-7, this indicates that in general they have a concept of a motor adaptability. 附图6和7显示了可以在该装置的近端部上包含有一个额外的模制件60的情况。 6 and 7 show the case may contain an additional molding 60 on the proximal portion of the device.

附图5显示了依据本发明的装置的一种可行的制造方法。 Figure 5 shows an apparatus of the present invention is a method for producing viable basis. 该装置由如上所述的适宜材料制成两个部件81和82。 The device consists of a suitable material as described above is made in two parts 81 and 82. 所述两个部件绕着通气导管83(未显示使附图简洁清楚)接在一起。 The two members around the airway tube 83 (not shown in the drawing simplicity and clarity) together. 通气导管适于放入特别设计的孔道84中。 Ventilation catheter 84 is adapted into a specially designed channel. 在这个实例中,颊间隙固定件90与囊94模塑成一体。 In this example, the buccal cavity fixing member 90 molded integrally with the balloon 94. 该装置的顶端包含有一系列或数个孔洞91、92和93。 The tip of the apparatus comprises a series of or several holes 91, 92 and 93. 在本文中,“数个(plurality)”指的是一个或多个。 As used herein, "several (Plurality)" refers to one or more. 这些孔洞增加了所述顶端的柔韧性,在使用时其有助于装置的插入和定位。 The apertures increase the flexibility of the tip, which facilitates the use of the insertion and positioning means. 这些孔洞也影响到顶端的柔软度和柔韧性(pliability),这些孔洞的存在使得所述顶端相对于由实心塑料材料制成的顶端更为柔软。 These holes also affect the softness and pliability of the tip (pliability), such that the presence of these holes relative to the distal tip made of a solid plastic material is softer. 通常,材料越柔软则对病人组织损伤的可能性越小。 Generally, the material is soft tissue damage to the patient less likely. 从附图4和5中也能明显地看到该装置总体上的内凹特性。 From figures 4 and 5 can clearly see on the device characteristics of concave overall.

在这些实施例中,可从这些附图中明显看出的另一个特征是所述装置的远顶端逐渐变细成一个平缓的锥形端。 In these embodiments, other features may be apparent from these figures is that the distal tip of the device tapers to a gentle tapered end. 这个逐渐变细的端部将放在或楔入喉部和食道入口之间。 The tapered or wedge on the end portion between the inlet throat and esophagus.

可从附图4到7(含)中看出并理解制造依据本发明的通气装置的一种方法。 As can be seen, and a method for producing ventilation means according to the present invention is understood from figures 4 to 7 (inclusive) in. 基本上附图7中的装置由两个部件61和62组成,再加上一个模制件64,所述模制件64包含一个15mm的连接件或其他连接件,以将所述装置连接到吸气式麻醉系统上。 BRIEF means 7 essentially two parts 61 and 62 plus a molding 64, the molding member 64 includes a connection member a 15mm or other connector to connect the device to the air-breathing anesthesia systems. 标为61的是模制件腹面或前模制件,即与病人的喉入口和舌部接触的部分。 61 is labeled ventral or front molding molding, i.e., portion in contact with the laryngeal inlet and the patient's tongue. 标为62的为模制件背面或后模制件,即面离腹面部分的另一侧部。 Labeled as molding or after molding the back surface 62, i.e. face away from the ventral portion of the other side portion. 这些术语,即“腹面”和“背面”,将贯穿于本说明书中。 These terms, i.e. "ventral" and "back" will be used throughout the present specification.

备选地,所述装置也可包含一个独立的通气导管63,放在分别形成于模制件62和61的内体上的孔道66、67中。 Alternatively, the device may also include a separate airway tube 63, channels 66, 67 formed on the body 62 in the inner molding 61 and, respectively. 然而,在一个特别优选的实施例中,不需要所述的独立导管63。 However, in a particularly preferred embodiment, it does not require a separate conduit 63. 在这个实施例中,导管63、模制件62和61由硅胶制成,而模制件64和68则由聚丙烯制成。 In this embodiment, conduits 63, 62 and the molding 61 is made of silicone, while 64 and 68 by molding polypropylene. 两个聚丙稀模制件中较大的一个(68)(图中没标)设计成可防止所述装置过深地(beyond a certain point)进入到病人的口腔中。 Two polypropylene moldings larger one (68) (not labeled in the drawing) of the device is designed to be prevented from too deeply (beyond a certain point) into the patient's mouth.

通气导管可具有任何适宜的直径、或横截面(如该导管不是圆形)。 Ventilation catheter may have any suitable diameter, or cross-section (e.g., the conduit is not circular). 通常用于所述通气装置成人型号中的是9mm的导管。 Said venting means generally used for adults is 9mm model conduit.

在组装过程中,将模制件61和62粘接、胶合、焊接(包括但不限于热焊接和激光焊接)或以其他方法固接在一起。 During assembly, the molding 61 and an adhesive 62, glued, welded (including but not limited to heat welding and laser welding) or otherwise fixed together. 模制件61和62可由具有不同硬度的材料制成,再采用上述简单、精致而低成本的方法固接在一起。 61 and 62 made of molding material having a different hardness may be formed, then the above-described simple, elegant and cost-effective way fixed together. 因而,包含喉部囊的前部件(61)可由比后部件柔软的材料制成。 Thus, the throat comprising a front bag member (61) made of a material softer than the rear part. 通常,前部件61的肖氏A级硬度在0到20之间,更加优选为0到15、更进一步优选为4到12。 Typically, the front part 61 of a Shore A hardness between 0-20, more preferably 0-15, still more preferably 4-12.

通常后部件62的肖氏硬度值为20到60,更为优选为30到40。 The rear member 62 is generally a Shore hardness value of 20 to 60, more preferably from 30 to 40.

也可以将一个额外通道70或数个通道结合于该装置的主体中,所述通道并排在通气导管的旁边。 70 is also an additional channel or several channels may be incorporated in the main body of the apparatus, the channel side by side next to the ventilation catheter. 有关这方面的一个例子显示在附图8中。 An example in this regard is shown in Figure 8. 在使用期间,该通道使得可将其他导管或导线插入到食道中,而不需要将所述装置移开或干扰到所述装置。 During use, the passage so that other catheters or guide wire may be inserted into the esophagus, the device without the need to remove or disturb the device. 例如,现在口胃插管法(orogastric intubation)已成为可能。 For example, now the mouth stomach intubation (orogastric intubation) has become possible.

如附图9所示,在另一个变化中,通气装置结合了一个纵向的裂缝,其大体上沿着通道的整个长度方向延伸。 As shown in FIG. 9, in another variation, the ventilation means incorporates a vertical crack which extends substantially along the entire longitudinal direction of the channel. 这就使得在使用期间可将其他导管或导线(探条、探针)插入或抽出,而不会干扰到罩具。 This allows wires or other catheters (bougie, probes) can be inserted or withdrawn during use without interfering with the cover. 另外,这个裂缝设置也意味着可以将通气装置从其他导管和导线中分开,并可在保持其他导管或导线在原位不受影响的情况下,将所述通气装置从病人身上拿开。 Further, this also means that cracks may be provided separate from the venting means and the other wire catheters, and other catheters or guide wire in holding in place the case is not affected, the venting means take away from the patient.

附图10显示了本发明的另一个实施例,并且显示了所述装置在其纵轴方向上的曲线形状。 Figure 10 shows another embodiment of the present invention, and shows the curve shape of the device in its longitudinal direction. 这个形状被设计成与接受麻醉的病人的口腔和咽喉腔道相适配。 This shape is designed to patients undergoing anesthesia of the mouth and throat cavity adapted. 所述纵轴为附图10.4中所示的轴线,即附图中直的虚线,其从通气导管的近端部延伸到囊的远顶端。 The longitudinal axis is shown in the accompanying drawings 10.4, i.e. the straight broken line in the drawings, which extends from the proximal end portion of the ventilation catheter to the distal tip of the balloon.

在附图10.3中显示了颊间隙固定件的一个优选实施例的一般形状。 It shows the general shape of a preferred embodiment of the fixing member in the buccal cavity 10.3 in the figures. 通常将标为100的所述固定件制成环绕着通气导管101。 Generally designated as the fixing member 100 is formed surrounding the airway tube 101. 然而,如上所述,不一定需要一个独立的导管,也可由形成于固定件主体之内的孔道构成一个管状的通道。 However, as described above, do not necessarily need a separate conduit, or may be formed in the inner bore of the holder main body constitutes a tubular passage. 固定件的部分102、103在导管101的两侧伸出,形成一个大体上椭圆形的截面。 Portion of the fixing member 102, 103 extending on both sides of the conduit 101, forming a substantially elliptical cross section. 从附图10.1和10.5以及附图17和18可看出,颊间隙固定件的宽度是不一致的,而是沿着其长度方向发生变化。 10.1 and 10.5 as well as from the drawings 17 and 18 can be seen in the drawings, the width of the buccal cavity fixing member is inconsistent, but vary along its length. 这与现有技术中类似装置的通气导管形成了对比,所述现有技术通气导管其横截面大体上是一致的。 This is in contrast with the prior art ventilation catheter similar devices, the prior art venting conduit whose cross section is substantially uniform. 在本文中,所述的宽度指的是两边之间的尺寸,即以垂直于该装置的纵轴方向、以及一个大体上平行于囊的开口面所处平面的平面为基准计算。 Herein, the width refers to the dimension between the two sides, i.e., perpendicular to the longitudinal axis of the device, and substantially parallel to the plane of a plane in which the balloon is calculated on the basis of the opening surface. 所述固定件的宽度在该装置的近端部最窄,接着其宽度增加到最大,然后其宽度再减小,直到与喉部囊的近侧相接。 The width of the fixing member in the narrowest portion of the proximal end of the device, then increases to a maximum width, and its width decreases again, until the balloon proximal contact with the throat. 因此,固定件的最大宽度处位于通气导管的近端部和喉部罩具的近端部之间。 Thus, the maximum width of the fixing member is positioned between a proximal portion and a proximal portion having a throat cover the ventilation catheter. 一般而言,如果宽度最大部分更加靠近喉部罩具的一端、而不是更靠近装置的近端部,如附图17A和B所示,则会是一个有利点。 In general, if the maximum width of the throat portion closer to one end of an enclosure, rather than closer to the proximal end of the device, as shown in figures 17A and B, and it will be advantageous to a point. 在使用中,这就使得最大宽度部分能最接近地位于病人的舌前部。 In use, such that the maximum width portion which can be positioned forward part closest to the patient.

关键的一点是,固定件的高度H不以相同的方式发生变化,而是沿着其纵轴方向大体保持相同。 The key point is that the height H of the fixing member does not change in the same manner, but remains substantially the same along its longitudinal axis. 这点完全不同于传统的通气导管。 This is completely different from conventional ventilation catheter.

显然依据前述可看出椭圆形在最宽处的宽度W大于相同处的高度H。 Clearly based on the elliptical shape can be seen in its widest width W greater than the height at the same H. 例如,对于依据本发明的成人用通气装置,固定件在其最宽处的宽度W将在3.5cm到4.5cm的范围之中,而高度H将在1.25cm到1.75cm的范围之中。 For example, for an adult according to the present invention the ventilation means fixing member in its widest width W and the height H would be in the range 1.25cm to 1.75cm to 3.5cm to 4.5cm in the range of. W/H的优选比率为2.7±10%。 Preferably the ratio W / H is 2.7 ± 10%.

所述固定件的形状的一个重要特征是其上部外表面104和下部外表面105的轮廓。 The shape of the fixing member is an important feature of the contour of its upper outer surface 104 and a lower outer surface 105. 这两个外表面均为凸形,并且在其最宽处为平滑的曲面。 These two outer surfaces are convex, and at its widest point as a smooth curved surface. 这点不仅使其易于使用,而且更重要的是,在使用中与舌部接触的下部表面105,其轮廓与病人舌体后部的形状相适配,并且下部表面105足够柔软,可变形而与病人舌体后部的形状相吻合。 This not only makes it easy to use, and more importantly, in use, a lower surface in contact with the tongue portion 105, the shape of the contour of the rear tongue of the patient is adapted, and the lower surface 105 is sufficiently soft, deformable and patient body shape of the back of the tongue coincides.

在附图16中显示了另一个实施例。 It shows another embodiment 16 of the accompanying drawings. 在这个实施例中,通气导管111仅部分地包在通气装置110的主体中。 In this embodiment, the ventilation catheter 111 is only partially wrapped in the body aeration device 110. 导管的远端部穿入,并且完全穿过通气装置110的主体,从而在囊中形成一个开口113。 Penetrating the distal end portion of the catheter, and the venting means 110 completely through the body, thereby forming an opening 113 in the capsule. 在这个实施例中,显示了一个具有不同轮廓的固定件。 In this embodiment, there is shown a fixing member having a different profile. 在这个实施例中,在使用中与舌部接触的下部表面115,其形状为平滑的凹形,同时上部表面为大体上凸形。 In this embodiment, the lower surface 115, in use, in contact with the tongue portion, which is a smooth concave shape, while the upper surface is substantially convex.

一旦连接在一起,所述装置实际上即可成为一个整体的构造。 Once connected, the device can actually be a unitary construction. 也就是说,各个部件构成了一体。 That is, the respective components are integrally constituted. 如果所述装置可重复使用,这将使消毒操作简易化,以及增加其可靠性。 If the device is reusable, which will be simplified sterilization operation, and increased reliability.

然而,不一定非得一体构造。 However, it does not necessarily have a unitary construction. 例如,如需要,也可将颊间隙固定件制成一个独立的部件(未显示),再将所述独立的颊间隙固定件套(threaded)在通气导管的上方、周围或上面。 For example, if desired, can also be made a member buccal cavity separate fixing member (not shown), then separate the buccal cavity fastener sleeve (threaded) above the ventilation catheter, around or above. 这个设计使得麻醉师在使用所述装置时可以根据需要选择用或不用固定件。 This design makes use of the device when the anesthetist may select with or without fixing member as needed. 当然还需要采用某种紧固方式来将固定件紧固到囊或导管上。 Of course, also we need to use some fastening means fastening member secured to the balloon or the catheter. 固定或紧固塑料部件的方式众所周知,比如扣式(snap-fit)连接件。 Fixed or known fastening plastic parts, such as button (snap-fit) connection.

这个选择增加了固定件设计方面的可选择性。 This option increases the optional fixing member design. 可以采用紧固在通气导管一端或两端的弹簧片的形式。 Fastened airway tube form one or both ends of the leaf spring may be employed. 另外,也可使用膨胀式结构。 Further, the expandable structure may be used. 如前文所述的膨胀式囊。 The inflatable bladder previously described. 迄今为止,这种技术还从未用来将一个颊间固定件结合到此类装置上。 To date, this technique has never been used to bond between a member fixed to the cheek such devices.

附图17和18显示了另外两个实施例。 Figures 17 and 18 show two additional embodiments. 附图中显示了依据本发明的这些实施例的流线型的、一体的构造,其中囊部分121平滑地与颊间隙固定件部分122相接。 Shown in the drawings streamlined, unitary construction of these embodiments of the present invention according to which the balloon portion 121 smoothly and buccal cavity portion 122 in contact with the fixing member. 在这些附图中,显示了其他一些关键的特征。 In these figures, it shows a number of other key features. 例如,通气导管进入到喉部囊时,其接通了三个单独的孔口123、124和125。 For example, the ventilating duct into the throat to the balloon, which is turned on three separate apertures 123, 124 and 125. 这将极大地降低通气导管堵塞的可能性。 This will greatly reduce the possibility of blockage of the ventilation duct. 与囊/杯的近端部连接的固定件的远端部的形状,以这种方式设计:所述装置在使用时,从解剖结构上看,所述固定件的远端部能恰当地放在舌下溪部(舌下沟、会厌谷)(valecullae)之中及其周围。 The shape of the distal end portion of the fixing member connected to the proximal end of the balloon / the cup, designed in this way: the device is in use, the anatomical structure, the distal end portion of the fixing member can be appropriately placed among the sublingual Creek section (sublingual ditch, epiglottis Valley) (valecullae) and its surroundings.

囊的远顶端126已做切除处理,实际上现在为凹形。 The capsule has done far top 126 cut processing, in fact is now concave. 这使得施加在甲状和环状软骨以及负责喉部结构供应的血管和神经上的压力比使用现有技术装置的情况小。 This makes the application of the thyroid and cricoid cartilage, and is responsible for pressure vessels and nerve supply larynx is smaller than the case of using the prior art devices. 这个所谓的凹形顶端可以采用多种不同的形状和样式。 This so-called concave tip can take many different shapes and styles. 所述顶端可以“平切”,从而该顶端的端部为大体平直。 The tip may be "truncated", so that the end portion of the tip is substantially flat. 或者是如附图17A所示的顶端具有明显的凹入。 Or obvious concave tip as shown in figures 17A. 在凹入的底部是一个如下所述的构成胃管通道的端部的孔口。 It is a recessed bottom portion of the opening end of the channel tube constituting follows. 总而言之,这种切除处理包含任何相对于现有技术的装置可降低所施加的压力的顶端。 In summary, this removal process can comprise any relative decrease in pressure applied to the top of the prior art devices.

提供独立于通气导管的一个又一个胃管通道,其从连接件128附近的所述装置近端部的开口127延伸到囊远顶端的开口129(更清楚地显示于附图17E中)。 Providing an independent ventilation catheter tube and a passage extending from the open proximal end of the device near the connecting portion 128 of the opening 127 to the distal tip of the balloon 129 (more clearly shown in the drawings. 17E). 使用期间在出现胃液反流(passiveregurgitation)的情况下,通过所述胃管可检测到任何的胃吸出物。 During use in the case of gastric reflux (passiveregurgitation) through a gastric tube may be detected by any gastric aspirate. 这也提供了一个插入小孔径胃管(Freka导管)的途径。 This also provides a way to insert a small aperture tube (Freka catheter) is.

该装置另一个新颖性特征为位于囊部分近端部的突出顶端或凸缘130。 Another novel feature of the device is located in the top of the balloon or flange projecting portion 130 of the proximal portion. 所述突出顶端的尺寸和形状使得其可符合解剖结构地置于会厌软骨上,从而确保具有适宜的密封性,并将会厌软骨往回拉,以免会厌软骨向前压住喉入口,从而避免了气流的阻塞。 The protrusion is sized and shaped such that it can conform to the top of the anatomy placed on the epiglottis, to ensure proper sealing with, and epiglottis to pull back, so as to suppress the epiglottis forwardly laryngeal inlet, thus avoiding the blocking airflow. 该顶端采用了叶片状的结构,从喉部囊向着通气导管的近端部方向伸出。 The top high-blade-like configuration, the balloon from the throat portion toward the proximal end of the ventilation catheter extending direction. 可从附图17中看到其相对的尺寸和形状。 You can see the relative size and shape from the Figure 17. 最佳的尺寸和形状将通过实验进行确定。 The optimum size and shape will be determined by experiments. 申请人从未见过任何具有这个特征的现有技术的罩具。 Applicants have never seen any of the prior art with the cover having this feature.

附图18也显示了构造方面以及喉部囊的某些新颖性特征。 Figure 18 also shows the configuration of certain aspects and novel features of the throat of the balloon. 首先看囊,在这个实施例中,在囊相对的两侧采用了薄的柔韧性凸缘140和141。 First look at the balloon, in this embodiment, the opposing sides of the balloon uses a thin, flexible flanges 140 and 141. 优选地,将这些凸缘制成囊模制件的一个组成部分,并且,由于用来制造囊的材料非常地柔软,这些凸缘格外地柔软和柔韧。 Preferably, the flanges are made an integral part of the balloon molding, and, due to the materials used to fabricate the balloon is very soft, the flanges exceptionally soft and pliable. 所述凸缘的作用即为允许任何不同病人喉入口形状的差异,以及有助于在囊和喉部结构之间形成一个高效的密封。 Is the action of the flange to allow any differences in different patients laryngeal inlet shape and to facilitate efficient formation of a seal between the balloon and the larynx. 通过这样的设计、以及将所述囊设计成在解剖结构上具有密切的适配性,从实验中获得的密封压力完全可以超过30cm水柱。 By this design, the bladder and is designed to have a close fit of the anatomical structure, the sealing pressure obtained from the experiment completely than 30cm of water.

在附图18中所示的羽毛状凸缘140和141为不连续结构,但实际上它们可在囊的远端部相互连接(如附图18C和D)。 Feathery flange 18 as shown in the figures 140 and 141 is not a continuous structure, but in fact they may be connected to each other (e.g., figures 18C and D) at the distal end of the balloon. 在这样的设计中,凸缘140和141成为一个一体的U形凸缘,环绕着喉部囊的大部分边缘。 In such a design, the flanges 140 and 141 become an integral U-shaped flange around the majority of the edge of the throat of the balloon.

在附图18中也显示了一个二体式的构造。 In Figure 18 also shows a two-body structure. 两部件为一个上部弯曲的部件145,其外表面为大体凸形,以及一个下部弯曲的部件146,其外表面为大体凹形,并且所述下部部件146包含有在使用中与病人喉入口接触的喉部囊的面。 Two upper member is a curved member 145, a generally convex outer surface, and a lower curved member 146, the outer surface is generally concave, and the lower member 146 comprises a contact with the patient laryngeal inlet in use, throat sac faces. 在这两个部件之中形成有一个通气导管孔道,其从近端部147延伸到远端部或囊149,还形成有如上所述的第二通道。 Is formed in two parts has a bore airway tube extending from a proximal portion to a distal portion 147, or balloon 149, as described above is also formed with a second channel.

通过使用一种合适的、由材料专家选择的粘胶剂或通过焊接方法,将上部部件使用连接件150连接在一起。 By using a suitable, selected by the materials specialist glue or by a welding method, the upper member 150 are connected together using the connecting member.

有利地,上部部件145和下部部件由具有不同肖氏硬度的材料制成。 Advantageously, the upper member and the lower member 145 is made of materials having different Shore hardness. 因而,上部部件可由肖氏A级硬度在30到40范围中的材料制成,而下部部件可由较软的、硬度(相同硬度级)在4到12范围中的材料制成。 Accordingly, the upper member may be a Shore A hardness of the material in the range of 30 to 40 is made, and the lower member may be a relatively soft, hardness (same hardness grade) made of a material in the range from 4 to 12.

如需要,囊部件可由与装置的其他部件具有不同硬度的不同材料制成。 If desired, the bladder member may be formed of different materials having different hardnesses is made with the other components of the device. 这样的设计显示在附图17C中,图中所述装置由三个部件135,136和137组成,而不是两个部件。 Such a design shown in the drawings. 17C, in the apparatus of FIG. 135, 136 and 137 consisting of three parts instead of two parts.

然而,该通气装置精致和简单的设计的确使制造方法更为简单。 However, the ventilation means, and refined simple design does make manufacture easier method. 已发现所述装置可以在一个模具中模塑成一个一体的单一构造体。 It has been found that the device may be integrally molded into a unitary structure in a mold. 通过恰当地制出模具,以及充分考虑到如何将模具部分分开,则一体式制造是可能的。 By appropriately produced out of the mold, and fully consider how to split mold portion, the one-piece manufacture is possible. 可使用通常所知的二次注射成型方法制成模制件,其间材料被分别注射以制成部件的相关部分。 Can be made using a generally known method of injection molding a secondary molding, material is injected therebetween to form the relevant parts of each member. 另外,也可始终使用单次注射方法,部件可由硬度相同的材料制成,如希望,则在腹面或背面的全部或部分部位进行覆盖模塑,所述腹面或背面部位可采用肖氏硬度不同的材料。 Alternatively, you can always use a single injection method, the hardness of the member from the same material, as desired, the mold covering all or part of the ventral or the back portion, the back part may be employed ventral or different Shore hardness s material. 制造这种覆盖或层状制件的技术对于本领域的技术人员是熟知的。 Covered or layered manufacturing such articles to those skilled in the art is well known in the art.

现转到喉部囊的设计方面,在上述的实例中,囊部分预先由柔软的材料制成,或在制造过程中预先填入一种流体。 Turning now to the design of the throat of the balloon, in the above examples, the balloon portion of the previously made of a soft material, or pre-filled with one fluid in the manufacturing process. 在后一种情况中,囊的衬层应该由一种不吸收麻醉气体(比如笑气)的材料制成,从而在使用期间囊内部的压力不会升高。 In the latter case made of a material, the backing layer should not absorb the balloon from a gas anesthesia (for example laughing gas), whereby the interior of the balloon pressure does not rise during use.

在任一个备选的实施例中,囊可由一种适于吸收液体(比如水、粘液或血或相似的液体物质)的材料制成,吸收造成了囊尺寸的膨胀,从而其与病人喉入口粘膜软骨(mucocartilagenous)的解剖组织结构相适配。 In either alternative embodiment, the balloon may be adapted for absorbing liquid (such as water, mucous or blood or similar liquid material) is made of a material, resulting in the absorption of the inflatable bladder size, so that it laryngeal inlet of the patient mucosa cartilage (mucocartilagenous) adapted to the anatomical tissue structure. 这些材料将由材料专家进行选择,包括CRM(棉和人造纤维混纺),如在TAMPAX(注册商标名)棉塞、或压缩Gel Foam5(胶状泡沫)中所使用。 These materials are selected by the materials specialist, including CRM (cotton and rayon blends), as in TAMPAX (registered trade name) tampons, or compressed Gel Foam5 (colloidal foam) used.

在另一个备选的实施例中,囊将采用一种传统的可膨胀的形式。 In another alternative embodiment, the balloon will be used a conventional expandable form. 尽管这么做并非完美,原因是膨胀式囊本身固有的不利方面,但是将如上所述类型的、由如上所述的柔软材料制成的颊间隙固定件结合到一个可膨胀喉部罩式通气装置在与现有技术的膨胀式罩具相比较时,仍然代表了明显的进步。 Although do not perfect, because the inflatable bladder inherent negative aspect, but the binding of the type described above, buccal cavity made of a soft material as described above is fixed to an expandable member throat ventilation hood means when compared with the prior art expansion of an enclosure, still represent a significant improvement. 制造膨胀式囊的技术众所周知,无需于此描述。 Producing inflatable balloon is known, this need not be described.

总而言之,本发明的目标和目的为提供一种与解剖结构相适、可靠、简单和低成本的装置,所述装置用于自主呼吸的接受麻醉病人、或者从麻醉状态恢复过来的病人,以及某些处于隔离过程(weaning process)或复苏期间的重症监护病人,以提供一个安全、清洁、非手持式的输送氧气和/或麻醉气体的通气装置。 In summary, the goals and objectives of the present invention is to provide an adapter with the anatomy, reliable, simple and low-cost means, a receiving means for spontaneously breathing anesthetized patients, or recover from anesthesia over the patient, and a these are in the process of isolation (weaning process) or intensive care patients during resuscitation, to provide a safe, clean, non-handheld deliver oxygen and / or anesthetic gas venting means.

主要目标和目的如下:■提供一个简易的装置,具有现有通气装置的所有优点,并且具有与解剖结构相适的工作机理,以得到一种清洁的通气装置,用在自主呼吸的接受麻醉病人、麻醉后处于恢复阶段的病人或者处于无通气的隔离情况下(weaning off ventilatory support)的某些重症监护病人。 The main goals and objectives as follows: ■ provide a simple device having all the advantages of existing ventilation means, and a working mechanism and adapted to the anatomy, in order to obtain a ventilation cleaning means for spontaneous breathing in a patient receiving an anesthetic after anesthesia, the patient is in the recovery phase or in some intensive care patients in isolation without ventilation (weaning off ventilatory support) is.

■消除了目前用于麻醉操作的通气装置的所有不利点及复杂性。 ■ eliminate all the negative points of the ventilation device currently used for anesthesia and complexity.

■无需进行喉镜检查、插管或拔管,并且最低限度地侵入到咽喉部位。 ■ the need for laryngoscopy, intubation, or extubation and minimally invasive to the throat.

■属于用户友好型,仅需要对麻醉师、其他大夫、护士、医务辅助人员以及可能使用该装置的其他保健人员进行最少的培训。 ■ belong to the user-friendly, requiring only for anesthetists, other doctors, nurses, paramedics and other health care personnel may use the device performed with minimal training.

■一种有用的工具,用在意料外或/和预期中有难度的气管内插管的操作中。 ■ a useful tool, with the outer cannula unexpected or / and anticipated difficult endotracheal operation. 其有助于将气管内导管穿入通气装置,以及有助于定期的光纤插管或支气管窥镜检查。 The endotracheal tube that facilitates penetration venting means, and to facilitate regular fiber cannula or bronchoscopy.

■可自身固定,几乎不需要胶粘或系缚。 ■ can fix itself, almost no adhesive or tie.

总而言之,该装置具有一个连接件,突出的舌咽喉部位凸缘,以及预先填充的、依据解剖结构设计的喉部杯或囊,所述喉部杯或囊与喉入口部位确切的轮廓和形状相适配。 In summary, the apparatus having a connecting member projecting tongue throat flange, and a pre-filled, based on the anatomy of the throat cup or capsule design, the exact contour and shape of the throat with the laryngeal cup or inlet portion with balloon adaptation. 然而,这并不是说本发明不能与传统的膨胀式囊一同使用。 However, this is not to say that the present invention not be used with conventional inflatable bladder.

■连接件:15mm的ISO(国际标准组织)连接件,适于在麻醉后的恢复期间、在重症监护和复苏过程中与用作麻醉的任何气体输送系统连接。 ■ connection: ISO (International Standards Organization) 15mm connector adapted during recovery after anesthesia, connection to any of the gas delivery system used in intensive care and anesthesia recovery process.

■突出的舌咽部位/颊部凸缘:所有现有的通气插管装置均不同程度地具有向口腔右角或左角侧移、绕着其纵轴旋转180度、以及导气管移进移出的可能性,这会导致在通气装置的使用中其远端部的位移或错位,进而使所述通气装置起不到作用。 ■ glossopharyngeal projecting portion / flange cheek: All existing ventilation cannula means having different degrees side to the left corner or the right corner of the mouth, is rotated 180 degrees about its longitudinal axis, and moved into and out of the airway possibilities, which can lead to the displacement or dislocation of the distal end portion which, in use, the ventilation apparatus, thereby enabling said venting means no effect. 所述装置上的突出凸缘的组合以及所述装置由肖氏A级硬度小于60的材料制成,这两方面确保了颊间隙固定件能起到通气装置的一个中线位置的锚的作用,所述固定件通过平展在颊间隙中舌前部表面上,并且由内面(inner surface)侧向支撑,从而使通气装置更好地锚定在舌面上。 The composition and means of projecting flanges on the device is less than a Shore A hardness of 60 made of a material, both to ensure the anchor effect of the buccal cavity a centerline position fixing member can play a venting means, by the fixing member on the flat surface of the forward part buccal cavity, and the (inner surface) is supported by the inner lateral surface, such that the venting means better anchored in the surface of the tongue. 因而,不仅正中地稳固住通气装置,而且使通气装置停止侧移和/或旋转。 Thus, not only is centrally firmly live venting means, and that the lateral stop venting means and / or rotation. 在远端,突出凸缘与喉部杯扁平、成一定锥度的部位连接,即该装置管状部位的后下表面处,以在远端狭窄的咽下部提供进一步的锚定作用。 At a distal end, and a flange projecting throat flat cup, is connected to the taper portion constant, i.e., the lower surface of the rear portion of the tubular means to the distal end of the narrow hypopharynx provide further anchoring effect.

■与解剖结构相适的喉部杯:一种由柔软橡胶制成,或预先成型、预先膨胀/预先填充上合适的流体或柔软材料的杯,目的为不会对喉入口部位的粘膜和邻近组织结构施加大于22mm汞柱的内腔压力,从而避免压应力和切应力施加于咽喉粘膜上,进而确保一个连续不断的、流经周围组织毛细管的血液流动,进一步地确保了与所述装置接触的结构的血液供应的顺畅。 ■ with the anatomy of the throat cup suitable: those made from soft rubber or pre-formed, pre-inflated / pre-filled with a suitable fluid to the cup or soft material, will not object to the laryngeal inlet portion and adjacent mucosa structure pressure greater than 22mm Hg is applied to the lumen, thereby avoiding compressive stress and shear stress is applied to the mucous membrane of the throat, thereby ensuring a continuous, flow through the tissue surrounding the capillary blood flow, further ensuring the contact with the device smooth blood supply structure. 与解剖结构相适的杯密封性地围住喉入口,而不会使与其接触的组织扭曲变形。 With the anatomy suitable cup sealingly surrounds the laryngeal inlet without contact therewith cause tissue distortion.

在侧面上,杯或囊的向外突出部分被设计成与杓会厌皱襞的凹处和下外侧的梨状窝处相适配。 On the side, a cup or pouch outwardly projecting portion is designed to aryepiglottic fold lower lateral recess and adapted pyriform fossa. 逐渐变细的下端部使其易于插入到口腔及咽部,其将在位于中线的杓状软骨间皱襞(interytenoidfold)和位于侧边的楔状软骨和小角软骨上形成密封。 Tapering lower portion make it easy to insert into the oral cavity and pharynx, which folds in the midline between the arytenoid located on the side of small angle wedge cartilage and cartilage (interytenoidfold) to form a seal. 一个位于上部中线位置的裂缝将有助于杯插入到会厌上,而不会损伤到会厌或会厌被折叠和旋拧到所述杯状装置上的孔腔或远端开口中。 A neutral position in the upper cup is inserted into the fracture will help the epiglottis, the epiglottis without damaging or folding and epiglottis are screwed into the threaded bore on the distal end of the cup or opening device. 裂缝的上方是柔软的杯的更为扁平的部分,其被设计成可最佳地放置于会厌和舌底部之间的下咽部,从而将周围的组织与声门隔开。 Above the crack is more flexible flat portion of the cup, which is designed to be optimally placed between the epiglottis and hypopharynx bottom of the tongue, so that the tissue spaced from and surrounding the glottis. 尽管杯在声门的开口上提供了一个近乎自然以及与解剖结构相适的密封,但还是不能确保防止反流的胃内容物的吸入。 Although the cup provides a near seal with the anatomy and natural appropriate opening in the glottis, but still can not be secured to prevent aspiration of regurgitated gastric contents. 这种风险可以通过在高危病人上使用一个具有一个食道部件的改进装置而降低到最小。 This risk can be minimized by using a modified device with an oesophageal component in high risk patients.

■尺寸:尺寸可从0号到7号。 ■ Size: Size can number from 0 to 7.

1号到2号:新生儿和幼儿(体重3到20kgs)3号:儿童(体重21到50kgs)4号到5号:青少年(体重51到90kgs)6号到7号:成人(体重大于90kgs)优选地,可重复使用的装置或一次性装置由如上所述的材料制成,比如不含乳胶的SEBS或医用级硅胶。 No. 1 to No. 2: neonates and infants (weight 3 to 20kgs) 3: child (body weight 21 to 50kgs) 4 to 5: adolescents (body weight 51 to 90kgs) 6 to 7: adult (weighing more than 90kgs ) preferably, the device may be reusable or disposable device described above is made of a material, such as latex-free SEBS or medical-grade silicone. 可重复使用(可消毒)的装置能够至少使用40次。 Means a reusable (sterilizable) can be used at least 40 times. 设计的简单也使得重复使用装置的消毒变得简易。 Simple design makes reused without sterilization apparatus becomes simple. 一次性装置是一种优选的产品,其不仅更为经济,而且没有任何如在重复使用的装置中会发生的交叉感染的可能。 Disposable device is a preferred product, which is not only more economical, but there is no possibility of cross-infection as in the apparatus reusable occur.

从如上所述的设计特征看,依据本发明的装置大有可能比任何可比的装置的成本都要低。 See the design features described above, the device according to the present invention may be much lower cost than any comparable device.

■带有食道部件的NLA:所附加的食道部件将用在麻醉期间可能会发生胃部症状(gastricstatis)的病人身上,还用于重症监护室中导气管高度过敏的病人,所述病人均存在由于与通气隔离后引发的问题,这些问题已广受认同并且广为人知。 ■ NLA with esophagus member: the attached esophagus member will be used during anesthesia stomach symptoms (gastricstatis) may occur in patients, but also for intensive care patients highly allergic airway, the presence of both the patient Because of problems with the ventilation isolation caused by these problems have been widely recognized and well known. 几乎肯定地,这类病人最终需要进行气管切开术,以绕过其过敏的上部导气管,从而便于隔离。 Almost certainly, these patients eventually require tracheotomy, to bypass their upper airway allergic, thereby facilitating isolation. 患有慢性阻塞性/限制性呼吸疾病、哮喘和重度吸烟的病人更有可能发生由隔离引发的问题。 With chronic obstructive / restrictive respiratory disease, asthma patients and heavy smokers are more problems caused by the isolation may occur.

■插管式NLA意料中或/和意料外的存在插管困难的病人的病残情况或死亡率对于麻醉操作是一个公认的方面,对于面临此种情况的任何麻醉师来说则是一个挑战性的难题。 ■ NLA presence cannulated not unexpected and / or Unexpected difficult intubation of the patient's disability or death situation for anesthesia is a recognized aspect for any anesthetist faced with such situations, it is a challenge sexual problems. 在探条、Cook's导气管或光纤窥镜的帮助下,NLA的一个改进型(即在NLA的前部具有一个预先成型的纵向裂缝)将易于使气管内导管穿过NLA而进行插管。 In bougie Cook's airway or a fiber endoscope with help of a modified NLA (i.e., having a preformed longitudinal cracks in the front portion of the NLA) will tend to make the catheter through the endotracheal intubation and NLA.

■其他:对于NLA的每一个部件的形状、设计和工作机理,应能设想到有一些变化,不管这些变化是基于NLA性能改进的需要,还是基于其外形美观方面的需要。 Other ■: the shape, design and working principle of each member of the NLA, be conceivable to have some changes, in need thereof an aesthetic appearance Whether these changes are based on a need for improved performance NLA, or based.

整个通气装置可以制成一体,但基于其功能的改进或成本方面的考虑、或由于任何其他实际问题而需要的情况下,也可以先分别制出每一部件。 Venting means may be made integral whole, but based on the consideration of its improved function or cost, or for any other case where the practical problems need also to be made out of each member, respectively.

图1索引 Figure 1 Index

Claims (36)

1.一种用于人类和动物的通气装置,所述通气装置包含一根具有一个远端部和一个近端部的通气导管,所述通气导管的远端部环绕着一个喉部囊,所述喉部囊适于在病人的喉入口部位形成一个符合解剖结构的密接,其特征在于所述装置进一步包含一个颊间隙固定件,所述颊间隙固定件位于喉部囊和导管近端部之间的通气导管的上面或周围,并且所述颊部固定件适于与病人的舌前部相适配,其尺寸、形状、柔软度和轮廓适于提供稳定性和能够防止通气导管在使用中的旋转或侧向移动。 A distal end portion of the breather device for humans and animals, said venting means comprises a venting catheter having a distal portion and a proximal end portion of the ventilation catheter balloon surrounding a throat, the said throat portion is adapted to form a compliance balloon adhesion of the anatomy of the patient's laryngeal inlet portion, characterized in that said device further comprises a buccal cavity fixing member, said fixing member buccal cavity and the balloon catheter is located in the throat of the proximal portion or around the conduit between the vent and the fixing member adapted Tongue cheek portion is adapted to the patient, the size, shape, softness and stability profile suitable for providing ventilation catheter can be prevented and, in use, rotation or lateral movement.
2.依据权利要求1所述的通气装置,其中囊为非膨胀式,且预先制成一个形状,所述形状适于在病人的喉入口部位上形成符合解剖结构特征的密接。 2. The ventilation apparatus according to claim 1, wherein the balloon is non-inflatable and is pre-formed as a shape that is adapted to meet the anatomical features adhesion formed on a portion of the patient's laryngeal inlet.
3.依据任一项前述权利要求所声明的通气装置,其中所述喉部环形套预先充气膨胀或预先填充上合适的流体。 3. A breather device according to any one of the preceding claims stated, wherein the throat annular sleeve previously inflated or pre-filled with a suitable fluid.
4.依据任一项前述权利要求所述的通气装置,其中适于在病人喉入口部位上形成一个符合解剖结构特征的密接的喉部囊的面,具有设计成能与病人喉入口部位中的梨状窝处和杓会厌皱襞形成良好密封的鼓出部。 4. The aeration device according to any one of the preceding claims, wherein the throat portion is adapted to form a tight contact of the balloon comply with anatomical features of the patient's laryngeal inlet in the portion, designed to have the portion of the patient's laryngeal inlet piriform fossa and aryepiglottic folds bulged portion to form a good seal.
5.依据权利要求4所述的通气装置,其中适于在病人喉入口部位上形成一个符合解剖结构特征的密接的喉部囊的面,具有设计成能与舌下溪部(舌下沟、会厌谷valleculae)、会厌、杓会厌皱襞、梨状窝处形成良好密封,并且能绕着甲状和环状软骨的前部形成良好密封的鼓出部。 5. The breather device according to claim 4, wherein a form adapted to meet the anatomical features of the throat bladder adhesion surface portion on the patient's laryngeal inlet, designed to have a portion sublingual River (sublingual groove, vallecula valleculae), epiglottis, aryepiglottic folds, pyriform fossa to form a good seal, and the front portion can be about the thyroid cartilage and the annular bulged portion to form a good seal.
6.依据任一项前述权利要求所述的通气装置,其中适于在病人喉入口部位上形成一个符合解剖结构特征的密接的喉部囊的面,具有凹槽,所述凹槽设计成能确保供应喉部结构的重要的动脉、静脉和神经的通畅。 6. The breather device according to any one of the preceding claims, wherein a form adapted to meet the anatomical features of the throat bladder adhesion surface portion on the patient's laryngeal inlet, with a groove designed to ensure that the supply structure of the larynx important arteries, veins and nerves unobstructed.
7.依据任一项前述权利要求所述的通气装置,其中所述喉部杯的远顶端的尺寸和形状适于在使用中使其保持在上食道括约肌的上面。 7. A ventilation apparatus according to any one of the preceding claims, the size and shape of the distal tip wherein the cup is adapted to keep the throat above the esophageal sphincter in use.
8.依据权利要求7所述的通气装置,其中所述喉部杯的远顶端的形状为大体上凹形。 8. The ventilation device according to claim 7, wherein the shape of the distal tip is substantially concave cup throat.
9.权利要求1到3(含)中任一项所声明的通气装置,其中所述喉部杯预先由一种适于吸收液体的材料制成,所述液体比如水/粘液/血液或相似物质,从而引起所述喉部杯膨胀,进而与喉入口粘膜软骨的解剖结构相适配,所述材料例如用来制造TAMPAX(注册商标名)棉塞或压缩Gel Foam 5(胶状泡沫)的CRM(棉和人造纤维混纺)。 9. claims 1 to 3 (inclusive) an aeration device stated in any one of the throat cup material suitable for absorbing liquid from a pre-made, the liquid such as water / mucous / blood or similar substance to cause expansion of the throat cup, and further anatomy mucosa cartilage laryngeal inlet adapted to, for example, the material used to make Tampax (registered trade name) or the compressed tampon Gel foam 5 (bubble gum) of CRM (cotton and rayon blends).
10.依据任一项前述权利要求所述的通气装置,其中所述颊间隙固定件具有一个第一面、即腹面,其大体上与喉部囊的开口面同处一个平面,并且所述颊间隙固定件的第一面的形状为大体凹形。 10. The breather device according to any one of the preceding claims, wherein the buccal cavity having a first fixing member surface, i.e., the ventral surface of the opening which is substantially the same throat bladder at a plane, and the cheek a first surface shape of the gap of the fixing member is generally concave.
11.依据任一项前述权利要求所述的通气装置,其中所述颊间隙固定件从喉部囊的近端部向着通气导管的近端部延伸,从而囊和颊间隙固定件成为一体构造。 11. The ventilation device according to any one of the preceding claims, wherein said fixing member buccal cavity extending from a proximal portion of the balloon toward the proximal end of the throat portion of the ventilation catheter, so the balloon and fixing members integrally buccal cavity structure.
12.依据任一项前述权利要求所述的通气装置,其中所述颊间隙固定件的宽度W不一致,在喉部囊和通气导管的近端部之中具有一个宽度点。 12. The ventilation device according to any one of the preceding claims, wherein said fixing member buccal cavity width W is inconsistent, the point having a width and a proximal portion of the balloon throat into the ventilation catheter.
13.如在权利要求12中所声明的通气装置,其中所述颊间隙固定件的宽度点更加靠近喉部囊、而不是更加靠近通气导管的近端部。 13. The ventilation device according to claim 12 stated in claim, wherein the width of the buccal cavity fixing point closer to the throat of the balloon member, rather than closer to the proximal end portion of the ventilation catheter.
14.如在任一项前述权利要求中所声明的通气装置,其中所述颊间隙固定件的宽度W在其最宽点处与处在同一点处的颊间隙固定件的高度H的比率为2.7±10%。 Ratio of 14. The breather device as claimed in any one of the preceding claims stated, wherein the width W of the buccal cavity fixing member at its widest point to the height H of the buccal cavity at the same point of the fixture was 2.7 ± 10%.
15.如在任一项前述权利要求中所声明的通气装置,其中所述颊间隙固定件与病人舌部接触的面为粗糙面,以在使用中增加与舌部的摩擦。 15. A ventilation device as claimed in any one of the preceding claims stated, buccal cavity wherein said fixing member surface portion in contact with the patient's tongue are roughened to increase friction in use, with the tongue portion.
16.依据任一项前述权利要求所述的通气装置,其中所述颊间隙固定件的尺寸可调整。 16. The ventilation device according to any one of the preceding claims, wherein the size of the buccal cavity fixing member is adjustable.
17.依据任一项前述权利要求所述的通气装置,其中所述颊间隙固定件制成一个部件,所述部件至少一部分可以滑动的形式装在通气导管上。 17. The ventilation device according to any one of the preceding claims, wherein said fixing member is made of a buccal cavity member, at least a portion of the member slidably mounted on the airway tube form.
18.如在任一项前述权利要求中所声明的通气装置,其中所述颊间隙固定件制成通气导管的整体的一部分。 18. A ventilation device as claimed in any one of the preceding claims stated, wherein the buccal cavity portion integrally formed ventilation catheter fixing member.
19.依据任一项前述权利要求所述的通气装置,其中所述颊间隙固定件、通气导管和喉部囊制成一体。 19. The ventilation device according to any one of the preceding claims, wherein said fixing member buccal cavity, throat airway tube and balloon are integrally formed.
20.依据任一项前述权利要求所述通气装置,其中所述喉部囊由肖氏A级硬度等于或小于40的材料制成。 20. A claim according to any preceding claim said venting means, wherein said throat portion of the balloon is equal to a Shore A hardness of less than 40, or a material formed.
21.依据权利要求20所述的通气装置,其中所述喉部囊由肖氏A级硬度在0到20之间的材料制成。 21. The ventilation apparatus according to according to claim 20, wherein said balloon is made of a throat Shore A hardness of the material between 0-20.
22.依据权利要求21所述的通气装置,其中所述喉部囊由肖氏A级硬度在4到12之间的材料制成。 22. A venting apparatus according to claim 21, wherein said balloon is made of a throat Shore A hardness of the material is between 4 and 12.
23.依据任一项前述权利要求所述的通气装置,其中所述喉部囊和颊间隙固定件的前部分、即腹面部分由肖氏硬度大体相同的材料制成。 23. A front portion of the aeration device according to any one of the preceding claims, wherein the throat fixture buccal cavity and the bladder, i.e., the ventral portion is made of a material substantially the same Shore hardness.
24.依据任一项前述权利要求所述的通气装置,其中所述装置的后部件或叫背面部件和所述装置的前部件或叫腹面部件由肖氏硬度不同的材料制成。 24. A venting apparatus according to any one of the preceding claims, wherein the components of the device or of the device called the back surface member and the front member is made of a member or ventral called a Shore hardness of different materials.
25.依据权利要求24所述的通气装置,其中所述后部件或背面部件由肖氏A级硬度小于60的材料制成。 25. A venting apparatus according to claim 24, wherein the rear member or the rear surface member of a Shore A hardness less than the material 60 is made.
26.依据权利要求25所述的通气装置,其中所述后部件/背面部件由肖氏A级硬度在25到45之间的材料制成,优选为在30到40之间。 26. A venting apparatus according to claim 25, wherein the rear member / material between the back surface member made of a 25-45 Shore A durometer, preferably between 30 to 40.
27.依据权利要求1和4到26(含)中任一项所述的通气装置,其中所述喉部囊为膨胀式。 27. A process according to claim 1 and 4 to 26 (inclusive) venting means as claimed in any one of the throat portion wherein the balloon is inflatable.
28.依据任一项前述权利要求所述的通气装置,其中所述装置进一步包含一个胃管通道,其从囊的突出顶端延伸到所述装置的近端部。 28. The ventilation device according to any one of the preceding claims, wherein the device further comprises a gastric tube passageway extending from the top of the protruding portion of the balloon to the proximal end of the device.
29.一种大体上描述于此的通气装置,所述描述通过参考附图2到18(含)中的任一幅所阐明。 29. A venting apparatus generally described herein, any of the one described with reference to the accompanying drawings by 2-18 (inclusive) is set forth.
30.一种制造通气装置的方法,包含以下步骤:(a)制出所述装置的第一部件和第二部件的模制件;(b)通过连接件将第一部件和第二部件接在一起。 30. A method for manufacturing a ventilation device, comprising the steps of: (a) manufactured by the molding of the first and second parts of the apparatus; (b) through the connecting member and the second member of the first contact member together.
31.依据权利要求30所述的方法,其中所述第一部件为装置的前部件、即腹面部件,其包含有喉部囊的面,而所述第二部件为后部件、即背面部件。 31. The method according to claim 30, wherein the first member is a front member of the device, i.e. ventral member, comprising a laryngeal surface of the balloon, and the second member is a rear part, i.e. the back member.
32.依据权利要求30或31所述的方法,其中所述第一和第二部件由肖氏硬度不同的材料制成。 32. A method according according to claim 30 or 31, wherein said first and second members are made of a Shore hardness of different materials.
33.一种制造包含有一根通气导管、一个喉部囊和一个颊间固定件的通气装置的方法,所述方法包含将所述装置形成一体的塑料模制件。 33. A method of manufacturing an airway tube comprising a throat portion between the bladder and venting means fixing member of a cheek, the method comprising the plastic molding of the integrally formed device.
34.如在权利要求33中所声明的制造方法,其中所述装置以注塑成型法制成。 34. The method for producing the stated claims 33, wherein said means for injection molding into the legal.
35.依据权利要求30到34中任一项所述的制造方法,其中所述制造方法应用在依据权利要求1到29所述的装置的制造方法上。 35. A method for producing 30 to 34 according to any one of claims, wherein the manufacturing method applied to the device manufacturing method according to claim 1 to 29.
36.一种大体上描述于此的制造方法。 36. A method of manufacturing a substantially described herein.
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